About this trial
There are two components to the study: a patient and a clinician study. The clinician study will include one-hour semi-structured interviews with oncology specialists to identify facilitators and barriers to integrating digital diet interventions into the clinical workflow, and to understand their needs and preferences for digital diet interventions. The patient study aims to investigate initial feasibility, efficacy and acceptability of the GutCheck app and intervention. It will last 9 weeks and involves 2 study visits and 2 active phases with a transition week and optional transition visit between phases. During active phases, participants will be asked to use the GutCheck app every day. Prior to the first active phase, participants will go through informed consent and app training. The first active phase will last two weeks and will focus on tracking participants' diet, gastrointestinal (GI) symptoms, and stress. The data collected during the first active phase will be used to identify any potential trigger foods that may contribute to GI symptoms, but only if the participant reports experiencing GI symptoms. Between active phases, participants will have one Transition Week, where results from the first phase are given to the participants with the option to attend a Transition Week Visit. The second active phase will last four weeks and will involve the message intervention. A single-blind, micro-randomized trial design will be used to repeatedly randomize participants to different intervention combinations, determining both the timing and frequency of intervention message delivery throughout the day. Lastly, there will be an exit visit and interview within a week from the intervention to collect post-intervention measures and ask about the participant's experience with the GutCheck app.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
≥18 years old
reside in or have received cancer care in Minnesota
own a smartphone • consent to install the GutCheck app and discontinue diet tracking in other lifestyle apps (e.g., MyFitness, Fitbit, Noom).
are English-speaking
Disqualifiers
Unable to participate in an interview
Trial design
Crossover
Treatments tested in this trial
Stool Sample
Diagnostic testParticipants who were selected to collect their stool samples will be mailed their second kit before the last week (week 8) of intervention. Participants will collect their stool sample during week 8 and mail them to be processed prior to the Exit Interview Visit.
App Activity
Other interventionParticipants will be asked to log their food and beverages, stress, and gastrointestinal symptoms daily. They will also track physical activity.
Treatment groups
Trial outcomes
Primary outcomes
Adherence of Diet Tracking
Average count of days where the participant tracked at least two episodes a day.
Adherence of Gastrointestinal (GI) Symptom and Stress Level Tracking
Average count of days of GI symptom and stress tracking combination (i.e., once a day for two weeks for both).
Locations
Sponsors and contacts
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Masonic Cancer Center, University of Minnesota
Lead sponsor
Minnesota Clinical Trials Network
Collaborator
This trial is not recruiting at the moment. You can still explore other options: